System and method for locating detachment zone of a detachable implant

ABSTRACT

A system and method for quickly detaching an implant and for locating the detachment zone of a detachable implant. A sensor determines a sudden change in the local environment as the sensor passes from within a microcatheter to being exposed to the vasculature. The sensor may be a temperature sensor, ultrasonic sensor, pressure sensor or the like. If the detachable implant assembly uses a heater coil to detach the implant, the heater coil may be used as a sensor. Additionally, the implant itself may be used as a sensor if a change in electrical resistance is detectable as the implant exits the microcatheter and changes shape.

RELATED APPLICATIONS

The present application claims priority from U.S. ProvisionalApplication Ser. No. 61/016,154, filed Dec. 21, 2007 entitled System andMethod for Locating Detachment Zone of a Detachable Implant, hereinincorporated by reference in its entirety. This application alsoincorporates by reference U.S. Provisional Application Ser. No.60/604,671, filed Aug. 25, 2004 entitled Thermal Detachment System ForImplantable Devices; U.S. Provisional Application Ser. No. 60/685,342filed May 27, 2005 entitled Thermal Detachment System For ImplantableDevices; U.S. patent application Ser. No. 11/212,830 filed Aug. 25, 2005entitled Thermal Detachment System For Implantable Devices; U.S.Provisional Application Ser. No. 61/016,180, filed Dec. 21, 2007entitled Method of Detecting Implant Detachment.

FIELD OF THE INVENTION

The present invention relates to systems and methods for deliveringimplant devices to a target site within the body of a patient. Thepresent invention also relates to systems and methods for detecting alocation of a detachment zone of a delivered implant device.

BACKGROUND OF THE INVENTION

Delivery of implantable therapeutic devices by less invasive means hasbeen demonstrated to be desirable in numerous clinical situations. Forexample, vascular embolization has been used to control vascularbleeding, to occlude the blood supply to tumors, to occlude fallopiantubes, and to occlude vascular aneurysms, particularly intracranialaneurysms. In recent years, vascular embolization for the treatment ofaneurysms has received much attention. As another example, the use ofmesh or scaffold devices such as stents to open blocked vessels or toretain embolic coils have also received much attention.

Several different treatment modalities have been employed in the priorart for deploying implant devices. For example, numerous repositionabledetachment systems for implant devices have been described in the priorart including U.S. Pat. No. 5,895,385 to Guglielmi et al. and U.S. Pat.No. 5,108,407 to Geremia et al., the contents of which are herebyincorporated by reference. Several systems, such as those disclosed inU.S. Pat. No. 6,500,149 to Gandhi et al. and U.S. Pat. No. 4,346,712 toHanda et al., the contents of which are hereby incorporated byreference, describe the use of a heater to detach and deploy the implantdevice.

Some percutaneously delivered detachable implant systems, such as thoseused to deliver occlusive coils to aneurysms, include a detachableimplant that is temporarily attached to a pusher mechanism within amicrocatheter. The pusher mechanism is used to advance the implant outof the distal end of the microcatheter. Once the implant has beenadvanced to a desired location relative to the microcatheter, referredto herein as a detachment zone, a detachment mechanism is employed todetach the implant from the pusher. It is important not to detach theimplant prior to reaching the detachment zone as the implant may gethung up in the end of the catheter and subsequently get deployed at anundesirable location in the body.

Typically, in order to determine whether the implant has been advancedto the detachment zone relative to the microcatheter, radiopaque markersare used on both the microcatheter and either the pusher, the implant,or both. Thus, an operator uses the radiopaque markers to monitor therelative positions of the microcatheter and the implant as the implantis being advanced with the pusher. Monitoring the positions of theradiopaque markers requires the use of an x-ray device during theprocedure. Using an x-ray imaging machine adds expense, complicates theprocedure, and adds another space-consuming machine to the areasurrounding the patient. Additionally, due to the coiled nature of theimplant, the view of the radiopaque markers can become blocked by thecoil.

SUMMARY OF THE INVENTION

The present invention is an implant delivery and detachment system usedto position and deploy implantable devices such as coils, stents,filters, and the like within a body cavity including, but not limitedto, blood vessels, fallopian tubes, malformations such as fistula andaneurysms, heart defects (e.g. left atrial appendages and sepalopenings), and other luminal organs.

The system comprises an implant, a delivery catheter (genericallyreferred to as the pusher or delivery pusher), a detachable joint forcoupling the implant to the pusher, a heat generating apparatus(generically referred to as the heater), and a power source to applyenergy to the heater.

In one aspect of the present invention, the implant is coupled to thepusher using a tether, string, thread, wire, filament, fiber, or thelike. Generically this is referred to as the tether. The tether may bein the form of a monofilament, rod, ribbon, hollow tube, or the like.Many materials can be used to detachably join the implant to the pusher.One class of materials are polymers such as polyolefin, polyolefinelastomer such as those made by Dow marketed under the trade name Engageor Exxon marketed under the trade name Affinity, polyethylene, polyester(PET), polyamide (Nylon), polyurethane, polypropylene, block copolymersuch as PEBAX or Hytrel, and ethylene vinyl alcohol (EVA); or rubberymaterials such as silicone, latex, and Kraton. In some cases, thepolymer may also be cross-linked with radiation to manipulate itstensile strength and melt temperature. Another class of materials ismetals such as nickel titanium alloy (Nitinol), gold, and steel. Theselection of the material depends on the capacity of the material tostore potential energy, the melting or softening temperature, the powerused for detachment, and the body treatment site. The tether may bejoined to the implant and/or the pusher by welding, knot tying,soldering, adhesive bonding, or other means known in the art. In oneembodiment where the implant is a coil, the tether may run through theinside lumen of the coil and be attached to the distal end of the coil.This design not only joins the implant to the pusher, but also impartsstretch resistance to the coil without the use of a secondary stretchresistant member. In other embodiments where the implant is a coil,stent, or filter; the tether is attached to the proximal end of theimplant.

In another aspect of the present invention, the tether detachablycoupling the implant to the pusher acts as a reservoir of stored (i.e.potential) energy that is released during detachment. Thisadvantageously lowers the time and energy required to detach the implantbecause it allows the tether to be severed by application of heatwithout necessarily fully melting the material. The stored energy alsomay exert a force on the implant that pushes it away from the deliverycatheter. This separation tends to make the system more reliable becauseit may prevent the tether from re-solidifying and holding the implantafter detachment. Stored energy may be imparted in several ways. In oneembodiment, a spring is disposed between the implant and pusher. Thespring is compressed when the implant is attached to the pusher byjoining one end of the tether to one of either the pusher or implant,pulling the free end of the tether until the spring is at leastpartially compressed, then affixing the free end of the tether to theother of the implant or the pusher. Since both ends of the tether arerestrained, potential energy in the form of tension on the tether (orcompression in the spring) is stored within the system. In anotherembodiment, one end of the tether is fixed as in the previousembodiment, and then the tether is placed in tension by pulling on thefree end of the tether with a pre-determined force or displacement. Whenthe free end of the tether is then affixed, the elongation (i.e. elasticdeformation) of the tether material itself stores energy.

In another aspect of the present invention, a heater is disposed on orwithin the pusher, typically, but not necessarily, near the distal endof the pusher. The heater may be attached to the pusher by, for example,soldering, welding, adhesive bonding, mechanical boding, or othertechniques known in the art. The heater may be in the form of a woundcoil, heat pipe, hollow tube, band, hypotube, solid bar, toroid, orsimilar shape. The heater may be made from a variety of materials suchas steel, chromium cobalt alloy, platinum, silver, gold, tantalum,tungsten, mangalin, chromium nickel alloy available from California FineWire Company under the trade name Stable Ohm, conductive polymer, or thelike. The tether is disposed in proximity to the heater. The tether maypass through the lumen of a hollow or coil-type heater or may be wrappedaround the heater. Although the tether may be disposed in direct contactwith the heater, this is not necessary. For ease of assembly, the tethermay be disposed be in proximity to, but not actually touching, theheater.

The delivery catheter or pusher is an elongate member with distal andproximal ends adapted to allow the implant to be maneuvered to thetreatment site. The pusher comprises a core mandrel and one or moreelectrical leads to supply power to the heater. The pusher may taper indimension and/or stiffness along the length, with the distal end usuallybeing more flexible than the proximal end. In one embodiment, the pusheris adapted to be telescopically disposed within a delivery conduit suchas a guide catheter or microcatheter. In another embodiment, the pushercontains an inner lumen allowing it to be maneuvered over a guide wire.In still another embodiment, the pusher can be maneuvered directly tothe treatment site without a secondary device. The pusher may have aradiopaque marking system visible with fluoroscopy that allows it to beused in conjunction with radiopaque markings on the microcatheter orother adjunctive devices.

In another aspect of the present invention, the core mandrel is in theform of a solid or hollow shaft, wire, tube, hypotube, coil, ribbon, orcombination thereof. The core mandrel may be made from plastic materialssuch as PEEK, acrylic, polyamide, polyimide, Teflon, acrylic, polyester,block copolymer such as PEBAX, or the like. The plastic member(s) may beselectively stiffened along the length with reinforcing fibers or wiresmade from metal, glass, carbon fiber, braid, coils, or the like.Alternatively, or in combination with plastic components, metallicmaterials such as stainless steel, tungsten, chromium cobalt alloy,silver, copper, gold, platinum, titanium, nickel titanium alloy(Nitinol), and the like may be used to form the core mandrel.Alternatively, or in combination with plastic and/or metalliccomponents, ceramic components such as glass, optical fiber, zirconium,or the like may be used to form the core mandrel. The core mandrel mayalso be a composite of materials. In one embodiment, the core mandrelcomprises an inner core of radiopaque material such as platinum ortantalum and an outer covering of kink-resistant material such as steelor chromium cobalt. By selectively varying the thickness of the innercore, radiopaque identifiers can be provided on the pusher without usingsecondary markers. In another embodiment, a core material, for examplestainless steel, with desirable material properties such as kinkresistance and/or compressive strength is selectively covered (by, forexample, plating, drawing, or similar methods known in the art) with alow electrical resistance material such as copper, aluminum, gold, orsilver to enhance its electrical conductivity, thus allowing the coremandrel to be used as an electrical conductor. In another embodiment, acore material, for example, glass or optical fiber, with desirableproperties such as compatibility with Magnetic Resonance Imaging (MRI),is covered with a plastic material such as PEBAX or polyimide to preventthe glass from fracturing or kinking.

In another aspect of the present invention, the heater is attached tothe pusher, and then one or more electrical conductors are attached tothe heater. In one embodiment a two of conductive wires runsubstantially the length of the pusher and are coupled to the heaternear the distal end of the pusher and to electrical connectors near theproximal end of the pusher. In another embodiment, one conductive wireruns the substantially the length of the pusher and the core mandrelitself is made from a conductive material or coated with a conductivematerial to act as a second electrical lead. The wire and the mandrelare coupled to the heater near the distal end and to one or moreconnectors near the proximal end of the pusher. In another embodiment, abipolar conductor is coupled to the heater and is used in conjunctionwith radiofrequency (RF) energy to power the heater. In any of theembodiments, the conductor(s) may run in parallel to the core mandrel ormay pass through the inner lumen of a substantially hollow core mandrel(for example, a hypotube).

In another aspect of the present invention, an electrical and/orthermally insulating cover or sleeve may be placed over the heater. Thesleeve may be made from insulating materials such as polyester (PET),Teflon, block copolymer, silicone, polyimide, polyamide, and the like.

In another aspect of the present invention, electrical connector(s) aredisposed near the proximal end of the pusher so that the heater can beelectrically connected to a power source through the conductors. In oneembodiment, the connectors are in the form of a plug with one or moremale or female pins. In another embodiment, the connector(s) are tubes,pins, or foil that can be connected with clip-type connectors. Inanother embodiment, the connector(s) are tubes, pins, or foil that areadapted to mate with an external power supply.

In another aspect of the present invention, the pusher connects to anexternal power source so that the heater is electrically coupled to thepower source. The power source may be from battery(s) or connected tothe electrical grid by a wall outlet. The power source supplies currentin the form of direct current (DC), alternating current (AC), modulateddirect current, or radiofrequency (RF) at either high or low frequency.The power source may be a control box that operates outside of thesterile field or may be a hand-held device adapted to operate within asterile field. The power source may be disposable, rechargeable, or maybe reusable with disposable or rechargeable battery(s).

In another aspect of the present invention, the power source maycomprise an electronic circuit that assists the user with detachment. Inone embodiment, the circuit detects detachment of the implant andprovides a signal to the user when detachment has occurred. In anotherembodiment, the circuit comprises a timer that provides a signal to theuser when a pre-set length of time has elapsed. In another embodiment,the circuit monitors the number of detachments and provides a signal orperforms an operation such as locking the system off when a pre-setnumber of detachments have been performed. In another embodiment, thecircuit comprises a feedback loop that monitors the number of detachmentattempts and increases the current, voltage, and/or detachment time inorder to increase the likelihood of a successful detachment.

In another aspect of the present invention, the construction of thesystem allows for extremely short detachment time. In one embodiment thedetachment time is less than 1 second.

In another aspect of the present invention, the construction of thesystem minimizes the surface temperature of the device duringdetachment. In one embodiment, the surface temperature at the heaterduring detachment is under 50° C. In another embodiment, the surfacetemperature at the heater during detachment is under 42° C.

The present invention is also a method and system for detecting thelocation of the detachment zone of a detachable coil as it exits thedistal tip of the microcatheter without using radiopaque markers.Various sensing techniques are used to detect a change in variouscorresponding parameters due to the environmental difference between theinside of the microcatheter and exposure to a target site in the body.

In another aspect of the present invention a temperature sensor isutilized to detect a change in temperature as the sensor exits themicrocatheter. The change in temperatures indicates that the detachableimplant is in a desired detachment zone.

In another aspect of the present invention a pressure sensor is utilizedto detect a change in pressure as the sensor exits the microcatheter.The change in pressure indicates that the detachable implant is in adesired detachment zone.

In another aspect of the present invention an ultrasound sensor isutilized to detect a change in environmental space as the sensor exitsthe microcatheter. When inside the microcatheter, the ultrasonic sensordetects the distance to the inner walls of the microcatheter. Whenoutside the microcatheter, the ultrasonic sensor detects the increaseddistance to the inner walls of the vascular lumen or aneurysm. Hence,the change in distance indicates that the detachable implant is in adesired detachment zone.

Yet another aspect of the present invention the detachable coil isutilized as a detection mechanism. During navigation to the target site,the coil is contained, in a straight configuration, within themicrocatheter. As the coil is pushed out of the microcatheter, itregains a curved configuration. If an electrical current is passedthrough the coil, the resistance to current flow through the coilchanges as it curves. This change in resistance is used as a detectionmechanism.

These and other aspects and features of the present invention will beappreciated upon consideration of the following drawings and detaileddescriptions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a cross-sectional side view of a first embodiment ofa detachment system according to the present invention;

FIG. 2 illustrates a cross-sectional side view of a second embodiment ofa detachment system according to the present invention;

FIG. 3A illustrates example direct signaling current according to thepresent invention;

FIG. 3B illustrates example alternating signaling current according tothe present invention;

FIG. 4 illustrates a cross-sectional side view of a third embodiment ofa detachment system according to the present invention;

FIG. 5 illustrates example temperature data of the surface of adetachment system as a function of time according to the presentinvention;

FIG. 6 illustrates a cross-sectional side view of an electricalconnector of a detachment system according to the present invention;

FIG. 7 illustrates a cross-sectional side view of radiopaque layers of adetachment system according to the present invention; and

FIG. 8 illustrates a cross-sectional side view of a detachment systemincluding a stent according to the present invention;

FIG. 9 illustrates a partially exploded perspective view of a deliverysystem according to the present invention;

FIG. 10 illustrates a cross-sectional side view of an electricalconnector of a detachment system according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Turning to FIG. 1, a detachment system 100 of the present invention, andspecifically the distal portion of the detachment system 100, isillustrated. The detachment system 100 includes a pusher 102 that ispreferably flexible. The pusher 102 is configured for use in advancingan implant device 112 into and within the body of a patient and,specifically, into a target cavity site for implantation and delivery ofthe implant device 112. Potential target cavity sites include but arenot limited to blood vessels and vascular sites, such as, e.g.,aneurysms and fistula, heart openings and defects, such as, e.g., theleft atrial appendage, and other luminal organs, such as, e.g.,fallopian tubes.

A stretch-resistant tether 104 detachably couples the implant 112 to thepusher 102. In this example, the tether 104 is a plastic tube that isbonded to the pusher 102. A substantially solid cylinder could also be adesign choice for the tether 104. The stretch resistant tether 104extends at least partially through the interior lumen of an implantdevice 112.

Near the distal end of the pusher 102, a heater 106 is disposed inproximity to the stretch resistant tether 104. The heater 106 may bewrapped around the stretch resistant tether 104 such that the heater 106is exposed to or otherwise in direct contact with the blood or theenvironment, or alternatively may be insulated by a sleeve, jacket,epoxy, adhesive, or the like. The pusher 102 comprises a pair ofelectrical wires, positive electrical wire 108 and negative electricalwire 110. The wires 108 and 110 are coupled to the heater 106 by anysuitable means, such as, e.g., by welding or soldering.

The electrical wires 108, 110 are capable of being coupled to a sourceof electrical power (not shown). As illustrated the negative electricalwire 110 is coupled to the distal end of the heater 106 and the positiveelectrical wire 108 is coupled to the proximal end of the heater 106. Inanother embodiment, this configuration may be reversed, i.e., thenegative electrical wire 110 is coupled to the proximal end of theheater 106 while the positive electrical wire 108 is coupled to thedistal end of the heater 106.

Energy is applied to the heater 106 from the electrical wires 108, 110in order to sever the portion of the tether 104 in the proximity of theheater 106. It is not necessary for the heater 106 to be in directcontact with the tether 104. The heater 106 merely should be insufficient proximity to the tether 104 so that heat generated by theheater 106 causes the tether 104 to sever. As a result of activating theheater 106, the section of the stretch resistant tether 104 that isapproximately distal from the heater 106 and within the lumen of animplant device 112 is released from the pusher 102 along with theimplant device 112.

As illustrated, the implant device 112 is an embolic coil. An emboliccoil suitable for use as the implant device 112 may comprise a suitablelength of wire formed into a helical microcoil. The coil may be formedfrom a biocompatible material including platinum, rhodium, palladium,rhenium, tungsten, gold, silver, tantalum, and various alloys of thesemetals, as well as various surgical grade stainless steels. Specificmaterials include the platinum/tungsten alloy known as Platinum 479 (92%Pt, 8% W, available from Sigmund Cohn, of Mount Vernon, N.Y.) andnickel/titanium alloys (such as the nickel/titanium alloy known asNitinol).

Another material that may be advantageous for forming the coil is abimetallic wire comprising a highly elastic metal with a highlyradiopaque metal. Such a bimetallic wire would also be resistant topermanent deformation. An example of such a bimetallic wire is a productcomprising a Nitinol outer layer and an inner core of pure referencegrade platinum, available from Sigmund Cohn, of Mount Vernon, N.Y., andAnomet Products, of Shrewsbury, Mass.

Commonly-assigned U.S. Pat. No. 6,605,101 provides a further descriptionof embolic coils suitable for use as the implant device 112, includingcoils with primary and secondary configurations wherein the secondaryconfiguration minimizes the degree of undesired compaction of the coilafter deployment. The disclosure of U.S. Pat. No. 6,605,101 is fullyincorporated herein by reference. Furthermore, the implant device 112may optionally be coated or covered with a hydrogel or a bioactivecoating known in the art.

The coil-type implant device 112 resists unwinding because the stretchresistant tether 104 that extends through the lumen of the implantdevice 112 requires substantially more force to plastically deform thanthe implant device 112 itself. The stretch resistant tether 104therefore assists in preventing the implant device 112 from unwinding insituations in which the implant device 112 would otherwise unwind.

During assembly, potential energy may be stored within the device tofacilitate detachment. In one embodiment, an optional spring 116 isplaced between the heater 106 and the implant device 112. The spring iscompressed during assembly and the distal end of the tether 104 may betied or coupled to the distal end of the implant device 112, or may bemelted or otherwise formed into an atraumatic distal end 114.

In one embodiment, the stretch resistant tether 104 is made from amaterial such as a polyolefin elastomer, polyethylene, or polypropylene.One end of the tether 104 is attached to the pusher 102 and the free endof the tether 104 is pulled through the implant 112 with the proximalend of the implant 112 flush to either the heater 106 (if no spring 116is present) or to the compressed spring 116. A pre-set force ordisplacement is used to pre-tension the tether 104, thus storing energyin an axial orientation (i.e. co-linear or parallel to the long axis ofthe pusher 102) within the tether 104. The force or displacement dependson the tether material properties, the length of the tether 104 (whichitself depends on the tether's attachment point on the pusher and thelength of the implant). Generally, the force is below the elastic limitof the tether material, but sufficient to cause the tether to severquickly when heat is applied. In one preferred embodiment wherein theimplant to be deployed is a cerebral coil, the tether has a diameterwithin the range of approximately 0.001 to 0.007 inches. Of course thesize of the tether can be changed to accommodate different types andsizes of other implants as necessary.

Turning to FIG. 2, another embodiment of a detachment system of thepresent invention, detachment system 200, is illustrated. Detachmentsystem 200 shares several common elements with detachment system 100.For example, the same devices usable as the implant device 112 withdetachment system 100 are also usable as the implant device 112 withdetachment system 200. These include, e.g., various embolic microcoilsand coils. The implant device 112 has been previously described withrespect to detachment system 100. As with the implant device 112, thesame identification numbers are used to identify otherelements/components of detachment system 100 that may correspond toelements/components of detachment system 200. Reference is made to thedescription of these elements in the description of detachment system100 as that description also applies to these common elements indetachment system 200.

With detachment system 200, an interior heating element 206 is used toseparate a section of a stretch resistant tube 104 and an associatedimplant device 112 from the detachment system 200. Detachment system 200includes a delivery pusher 202 that incorporates a core mandrel 218. Thedetachment system 200 further includes a positive electrical wire 208and a negative electrical wire 210 that extend through the lumen of thedelivery pusher 202.

To form the internal heating element 206, the positive electrical wire208 and the negative electrical wire 210 may be coupled to the coremandrel 218 of the delivery pusher 202. Preferably, the electrical wires208, 210 are coupled to a distal portion of the core mandrel 218.

In one embodiment, the positive electrical wire 208 is coupled to afirst distal location on the core wire 218, and the negative electricalwire 210 is coupled to a second distal location on the core wire 218,with the second distal location being proximal to the first distallocation. In another embodiment, the configuration is reversed, i.e.,the positive electrical wire 208 is coupled to the second distallocation and the negative electrical wire 210 is coupled to the firstdistal location on the core wire 218. When the positive electrical wire208 and the negative electrical wire 210 are coupled to the distalportion of the core mandrel 218, the distal portion of the core mandrel218 along with the electrical wires 208, 210 forms a circuit that is theinterior heating element 206.

The heater 206 increases in temperature when a current is applied from apower source (not shown) that is coupled to the positive electrical wire208 and the negative electrical wire 210. If a greater increase intemperature/higher degree of heat is required or desired, a relativelyhigh resistance material such as platinum or tungsten may be coupled tothe distal end of the core mandrel 218 to increase the resistance of thecore mandrel 218. As a result, higher temperature increases are producedwhen a current is applied to the heater 206 than would be produced witha lower resistance material. The additional relatively high resistancematerial coupled to the distal end of the core mandrel 218 may take anysuitable form, such as, e.g., a solid wire, a coil, or any other shapeor material as described above.

Because the heater 206 is located within the lumen of the tube-shapedtether 104, the heater 206 is insulated from the body of the patient. Asa result, the possibility of inadvertent damage to the surrounding bodytissue due to the heating of the heater 206 may be reduced.

When a current is applied to the heater 206 formed by the core mandrel218, the positive electrical wire 208, and the negative electrical wire210, the heater 206 increases in temperature. As a result, the portionof the stretch resistant tether 104 in proximity to the heater 206severs and is detached, along with the implant device 112 that iscoupled to the tether 104, from the detachment system 200.

In one embodiment of the detachment system 200, the proximal end of thestretch resistant tether 104 (or the distal end of a larger tube (notshown) coupled to the proximal end of the stretch resistant tether 104)may be flared in order to address size constraints and facilitate theassembly of the detachment system 200.

In a similar manner as with detachment system 100, energy may be storedwithin the system with, for example, an optional compressive spring 116or by pre-tensioning the tether 104 during assembly as previouslydescribed. When present, the release of potential energy stored in thesystem operates to apply additional pressure to separate the implantdevice 112, and the portion of the stretch resistant tether 104 to whichthe implant device 112 is coupled, away from the heater 206 when theimplant device 112 is deployed. This advantageously lowers the requireddetachment time and temperature by causing the tether 104 to sever andbreak.

As with detachment system 100, the distal end of the stretch resistanttether 104 of detachment system 200 may be tied or coupled to the distalend of the implant device 112, or may be melted or otherwise formed intoan atraumatic distal end 114.

FIG. 4 illustrates another preferred embodiment of a detachment system300. In many respects, the detachment system 300 is similar to thedetachment system 200 shown in FIG. 2 and detachment system 100 shown inFIG. 1. For example, the detachment system 300 includes a deliverypusher 301 containing a heater 306 that detaches an implant device 302.Detachment system 300 also utilizes a tether 310 to couple the implantdevice 302 to the delivery pusher 301.

In the cross-sectional view of FIG. 4, a distal end of the deliverypusher 301 is seen to have a coil-shaped heater 306 that is electricallycoupled to electrical wires 308 and 309. These wires 308, 309 aredisposed within the delivery pusher 301, exiting at a proximal end ofthe delivery pusher 301 and coupling to a power supply (not shown). Thetether 310 is disposed in proximity to the heater 306, having a proximalend fixed within the delivery pusher 301 and a distal end coupled to theimplant device 302. As current is applied through wires 308 and 309, theheater 306 increases in temperature until the tether 310 breaks,releasing the implant device 302.

To reduce the transfer of heat from the heater 306 to the surroundingtissue of the patient and to provide electrical insulation, aninsulating cover 304 is included around at least the distal end of theouter surface of the delivery pusher 301. As the thickness of the cover304 increases, the thermal insulating properties also increase. However,increased thickness also brings increased stiffness and a greaterdiameter to the delivery pusher 301 that could increase the difficultyof performing a delivery procedure. Thus, the cover 304 is designed witha thickness that provides sufficient thermal insulating propertieswithout overly increasing its stiffness.

To enhance attachment of the tether 310 to the implant device 302, theimplant device 302 may include a collar member 322 welded to the implantdevice 302 at weld 318 and sized to fit within the outer reinforcedcircumference 312 of the delivery pusher 301. The tether 310 ties aroundthe proximal end of the implant device 302 to form knot 316. Furtherreinforcement is provided by an adhesive 314 that is disposed around theknot 316 to prevent untying or otherwise unwanted decoupling.

In a similar manner as with detachment systems 100 and 200, energy maybe stored within the system with, for example, an optional compressivespring (similar to compressive spring 116 in FIG. 1 but not shown inFIG. 4) or by axially pre-tensioning the tether 104 during assembly. Inthis embodiment, one end of the tether 310 is attached near the proximalend of the implant device 302 as previously described. The free end ofthe tether 310 is threaded through a distal portion of the deliverypusher 301 until it reaches an exit point (not shown) of the deliverypusher 301. Tension is applied to the tether 310 in order to storeenergy in the form of elastic deformation within the tether material by,for example, placing a pre-determined force on the free end of thetether 310 or moving the taunt tether 310 a pre-determined displacement.The free end of the tether 310 is then joined to the delivery pusher 301by, for example, tying a knot, applying adhesive, or similar methodsknown in the art.

When present, the release of potential energy stored in the systemoperates to apply additional pressure to separate the implant device302, and the portion of the tether 310 to which the implant device 302is coupled, away from the heater 306 when the implant device 302 isdeployed. This advantageously lowers the required detachment time andtemperature by causing the tether 310 to sever and break.

The present invention also provides for methods of using detachmentsystems such as detachment systems 100, 200, or 300. The followingexample relates to the use of detachment system 100, 200, or 300 foroccluding cerebral aneurysms. It will, however, be appreciated thatmodifying the dimensions of the detachment system 100, 200, or 300 andthe component parts thereof and/or modifying the implant device 112, 302configuration will allow the detachment system 100, 200, or 300 to beused to treat a variety of other malformations within a body.

With this particular example, the delivery pusher 102, 202, or 301 ofthe detachment system 100, 200, or 300 may be approximately 0.010 inchesto 0.030 inches in diameter. The tether 104, 310 that is coupled nearthe distal end of the delivery pusher 102, 202, or 301 and is coupledthe implant device 112, 302 may be 0.0002 inches to 0.020 inches indiameter. The implant device 112, 302; which may be a coil, may beapproximately 0.005 inches to 0.020 inches in diameter and may be woundfrom 0.0005 inch to 0.005 inch wire.

If potential energy is stored within the detachment system 100, 200, or300, the force used to separate the implant 112, 302 from the pushertypically ranges up to 250 grams force.

The delivery pusher 102, 202, or 301 may comprise a core mandrel 218 andat least one electrically conductive wire 108, 110, 208, 210, 308, or309. The core mandrel 218 may be used as an electrical conductor, or apair of conductive wires may be used, or a bipolar wire may be used aspreviously described.

Although the detachment systems 100, 200, and 300 have been illustratedas delivering a coil, other implant devices are contemplated in thepresent invention. For example, FIG. 8 illustrates the detachment system300 as previously described in FIG. 4 having an implant that is a stent390. This stent 390 could similarly be detached by a similar method aspreviously described in regards to the detachment systems 100, 200, and300. In a further example, the detachment systems 100, 200, or 300 maybe used to deliver a filter, mesh, scaffolding or other medical implantsuitable for delivery within a patient.

FIG. 7 presents an embodiment of a delivery pusher 350, which could beused in any of the embodiments as delivery pusher 102, 202, or 301,which includes radiopaque materials to communicate the position of thedelivery pusher 350 to the user. Specifically, the radiopaque markermaterial is integrated into the delivery pusher 350 and varied inthickness at a desired location, facilitating easier and more precisemanufacturing of the final delivery pusher 350.

Prior delivery pusher designs, such as those seen in U.S. Pat. No.5,895,385 to Guglielmi, herein incorporated by reference, rely onhigh-density material such as gold, tantalum, tungsten, or platinum inthe form of an annular band or coil. The radiopaque marker is thenbonded to other, less dense materials, such as stainless steel, todifferentiate the radiopaque section. Since the radiopaque marker is aseparate element placed at a specified distance (often about 3 cm) fromthe tip of the delivery pusher, the placement must be exact or thedistal tip of the delivery pusher 350 can result in damage to theaneurysm or other complications. For example, the delivery pusher 350may be overextended from the microcatheter to puncture an aneurysm.Additionally, the manufacturing process to make a prior delivery pushercan be difficult and expensive, especially when bonding dissimilarmaterials.

The radiopaque system of the present invention overcomes thesedisadvantages by integrating a first radiopaque material into most ofthe delivery pusher 350 while varying the thickness of a secondradiopaque material, thus eliminating the need to bond multiple sectionstogether. As seen in FIG. 7, the delivery pusher 350 comprises a coremandrel 354 (i.e. the first radiopaque material), preferably made fromradiopaque material such as tungsten, tantalum, platinum, or gold (asopposed to the mostly radiolucent materials of the prior art designssuch as steel, Nitinol, and Elgiloy).

The delivery pusher 350 also includes a second, outer layer 352, havinga different radiopaque level. Preferably, outer layer 352 is composed ofa material having a lower radiopaque value than the core mandrel 354,such as Elgiloy, Nitinol, or stainless steel (commercially availablefrom Fort Wayne Metals under the trade name DFT). In this respect, boththe core mandrel 354 and the outer layer 352 are visible anddistinguishable from each other under fluoroscopy. The outer layer 352varies in thickness along the length of the delivery pusher 350 toprovide increased flexibility and differentiation in radio-density. Thusthe thicker regions of the outer layer 352 are more apparent to the userthan the thinner regions under fluoroscopy.

The transitions in thickness of the outer layer 352 can be preciselycreated at desired locations with automated processes such as grinding,drawing, or forging. Such automated processes eliminate the need forhand measuring and placement of markers and further eliminates the needto bond a separate marker element to other radiolucent sections, thusreducing the manufacturing cost and complexity of the system.

In the present embodiment, the delivery pusher 350 includes three mainindicator regions of the outer layer 352. A proximal region 356 is thelongest of the three at 137 cm, while a middle region 358 is 10 cm and adistal region 360 is 3 cm. The length of each region can be determinedbased on the use of the delivery pusher 350. For example, the 3 cmdistal region 360 may be used during a coil implant procedure, as knownin the art, allowing the user to align the proximal edge of the distalregion 360 with a radiopaque marker on the microcatheter within whichthe delivery pusher 350 is positioned. The diameter of each of theregions depends on the application and size of the implant. For atypical cerebral aneurysm application for example, the proximal region356 may typically measure 0.005-0.015 inches, the middle region 358 maytypically measure 0.001-0.008 inches, while the distal region 360 maytypically measure 0.0005-0.010 inches. The core mandrel 354 willtypically comprise between about 10-80% of the total diameter of thedelivery pusher 350 at any point.

Alternately, the delivery pusher 350 may include any number of differentregions greater than or less than the three shown in FIG. 7.Additionally, the radiopaque material of the core mandrel 354 may onlyextend partially through the delivery pusher 350. For example, theradiopaque material could extend from the proximal end of the coremandrel 354 to three centimeters from the distal end of the deliverypusher 350, providing yet another predetermined position marker visibleunder fluoroscopy.

In this respect, the regions 356, 358, and 360 of delivery pusher 350provide a more precise radiopaque marking system that is easilymanufactured, yet is readily apparent under fluoroscopy. Further, theincreased precision of the markers may decrease complications relatingto improper positioning of the delivery pusher during a procedure.

In operation, the microcatheter is positioned within a patient so that adistal end of the microcatheter is near a target area or lumen. Thedelivery pusher 350 is inserted into the proximal end of themicrocatheter and the core mandrel 354 and outer layer 352 are viewedunder fluoroscopy. The user aligns a radiopaque marker on themicrocatheter with the beginning of the distal region 360, whichcommunicates the location of the implant 112, 302 relative to the tip ofthe microcatheter.

In some situations, for example, small aneurysms where there may be anelevated risk of vessel damage from the stiffness of the delivery pusher350, the user may position the proximal end of the implant slightlywithin the distal end of the microcatheter during detachment. The userthen may push the proximal end of the implant 112, 302 out of themicrocatheter with the next coil, an adjunctive device such asguidewire, or the delivery pusher 102, 202, 301, or 350. In anotherembodiment, the user may use the radiopaque marking system to locate thedistal end of the delivery pusher outside the distal end of themicrocatheter.

Once the implant device 112, 302 of the detachment system 100, 200, or300 is placed in or around the target site, the operator may repeatedlyreposition the implant device 112, 302 as necessary or desired.

When detachment of the implant device 112, 302 at the target site isdesired, the operator applies energy to the heater 106, 206, or 306 byway of the electrical wires 108, 110, 208, 210, 308, or 309. Theelectrical power source for the energy may be any suitable source, suchas, e.g., a wall outlet, a capacitor, a battery, and the like. For oneaspect of this method, electricity with a potential of approximately 1volt to 100 volts is used to generate a current of 1 milliamp to 5000milliamps, depending on the resistance of the detachment system 100,200, or 300.

One embodiment of a connector system 400 that can be used toelectrically couple the detachment system 100, 200, or 300 to the powersource is shown in FIG. 6. The connector system 400 includes anelectrically conductive core mandrel 412 having a proximal endsurrounded by an insulating layer 404. Preferably the insulating layer404 is an insulating sleeve such as a plastic shrink tube of polyolefin,PET, Nylon, PEEK, Teflon, or polyimide. The insulating layer 404 mayalso be a coating such as polyurethane, silicone, Teflon, paralyene. Anelectrically conductive band 406 is disposed on top of the insulatinglayer 404 and secured in place by molding bands 414, adhesive, or epoxy.Thus, the core mandrel 412 and the conductive band 406 are electricallyinsulated from each other. The conductive band 406 is preferablycomposed of any electrically conductive material, such as silver, gold,platinum, steel, copper, conductive polymer, conductive adhesive, orsimilar materials, and can be a band, coil, or foil. Gold is especiallypreferred as the conductive material of the conductive band 406 becauseof the ability of gold to be drawn into a thin wall and its readyavailability. The core mandrel 412 has been previously described and maybe plated with, for example, gold, silver, copper, or aluminum toenhance its electrical conductivity.

The connector system 400 also includes two electrical wires 408 and 410which connect to the conductive band 406 and core member 412,respectively, and to a heating element at the distal end of a deliverysystem such as those described in FIGS. 1, 2, and 4 (not shown in FIG.6). These wires 408 and 410 are preferably connected by soldering,brazing, welding, laser bonding, or conductive adhesive, or similartechniques.

Once the user is ready to release the implant 112, 302 within thepatient, a first electrical clip or connector from a power source isconnected to a non-insulated section 402 of the core mandrel 412 and asecond electrical clip or connector from the power source is connectedto the conductive band 406. Electrical power is applied to the first andsecond electrical clips, forming an electrical circuit within thedetachment system 100, 200, or 300, causing the heater 106, 206, or 306to increase in temperature and sever the tether 104, 310.

Once the detachment system 100, 200, or 300 is connected to the powersource the user may apply a voltage or current as previously described.This causes the heater 106, 206, or 306 to increase in temperature. Whenheated, the pre-tensioned tether 104, 310 will tend to recover to itsunstressed (shorter) length due to heat-induced creep. In this respect,when the tether 104, 310 is heated by the heater 106, 206, or 306; itsoverall size shrinks. However, since each end of the tether 104, 310 isfixed in place as previously described, the tether 104, 310 is unable toshorten in length, ultimately breaking to release the implant device112, 302.

Because there is tension already within the system in the form of aspring 116 or deformation of the tether material 104, 310; the amount ofshrinkage required to break the tether 104, 310 is less than that of asystem without a pre-tensioned tether. Thus, the temperature and timerequired to free the implant device 112, 302 is lower.

FIG. 5 is a graph showing the relationship between the temperature atthe surface of PET cover 304 of the detachment system 300 and the timeduration in which the heater coil 306 is activated. As can be seen, thesurface temperature of the detachment system 300 during detachment doesnot vary linearly with time. Specifically, it takes just under 1 secondfor the heat generated by the heating coil 306 to penetrate theinsulating cover 304. After 1 second, the surface temperature of theinsulating cover 304 dramatically increases. Although different outerinsulating material may slightly increase or decrease this 1-secondsurface temperature window, the necessarily small diameter of thedetachment system 100, 200, or 300 prevents providing a thick insulatinglayer that may more significantly delay a surface temperature increase.

It should be understood that the embodiments of the detachment system100, 200, or 300 include a variety of possible constructions. Forexample, the insulating cover 304 may be composed of Teflon, PET,polyamide, polyimide, silicone, polyurethane, PEEK, or materials withsimilar characteristics. In the embodiments 100, 200, or 300 the typicalthickness of the insulating cover is 0.0001-0.040 inches. This thicknesswill tend to increase when the device is adapted for use in, forexample, proximal malformations, and decrease when the device is adaptedfor use in more distal, tortuous locations such as, for example,cerebral aneurysms.

In order to minimize the damage and possible complications caused bysuch a surface temperature increase, the present invention detaches theimplant device 112, 302 before the surface temperature begins tosignificantly increase. Preferably, the implant device 112, 302 isdetached in less than a second, and more preferably, in less than 0.75seconds. This prevents the surface temperature from exceeding 50° C.(122° F.), and more preferably, from exceeding 42° C. (107° F.).

Once the user attempts to detach the implant device 112, 302, it isoften necessary to confirm that the detachment has been successful. Thecircuitry integrated into the power source may be used to determinewhether or not the detachment has been successful. In one embodiment ofthe present invention an initial signaling current is provided prior toapplying a detachment current (i.e. current to activate the heater 106,206, or 306 to detach an implant 112, 302). The signaling current isused to determine the inductance in the system before the user attemptsto detach the implant and therefore has a lower value than thedetachment current, so as not to cause premature detachment. After anattempted detachment, a similar signaling current is used to determine asecond inductance value that is compared to the initial inductancevalue. A substantial difference between the initial inductance and thesecond inductance value indicates that the implant 112, 302 hassuccessfully been detached, while the absence of such a differenceindicates unsuccessful detachment. In this respect, the user can easilydetermine if the implant 112, 302 has been detached, even for deliverysystems that utilize nonconductive temperature sensitive polymers toattach an implant, such as those seen in FIGS. 1, 2, and 4.

In the following description and examples, the terms “current” and“electrical current” are used in the most general sense and areunderstood to encompass alternating current (AC), direct current (DC),and radiofreqeuncy current (RF) unless otherwise noted. The term“changing” is defined as any change in current with a frequency abovezero, including both high frequency and low frequency. When a value ismeasured, calculated and/or saved, it is understood that this may bedone either manually or by any known electronic method including, butnot limited to, an electronic circuit, semiconductor, EPROM, computerchip, computer memory such as RAM, ROM, or flash; and the like. Finally,wire windings and toroid shapes carry a broad meaning and include avariety of geometries such as circular, elliptical, spherical,quadrilateral, triangular, and trapezoidal shapes.

When a changing current passes through such objects as wire windings ora toroid, it sets up a magnetic field. As the current increases ordecreases, the magnetic field strength increase or decreases in the sameway. This fluctuation of the magnetic field causes an effect known asinductance, which tends to oppose any further change in current.Inductance (L) in a coil wound around a core is dependant on the numberof turns (N), the cross-sectional area of the core (A), the magneticpermeability of the core (μ), and length of the coil (l) according toequation 1 below:

$\begin{matrix}{L = {\frac{0.4\;\pi\; N^{2}A\;\mu}{l}.}} & {{Equation}\mspace{14mu} 1}\end{matrix}$

The heater 106 or 306 is formed from a wound coil with proximal anddistal electrically conductive wires 108, 110, 308, or 309 attached to apower source. The tether 104, 310 has a magnetic permeability μ₁ and ispositioned through the center of the resistive heater, having a lengthl, cross sectional area A, and N winds, forming a core as described inthe previous equation. Prior to detachment, a changing signaling currenti₁, such as the waveforms shown in FIGS. 3A and 3B, with frequency f₁,is sent through the coil windings. This signaling current is generallyinsufficient to detach the implant. Based on the signaling current, theinductive resistance X_(L) (i.e. the electrical resistance due to theinductance within the system) is measured by an electronic circuit suchas an ohmmeter. The initial inductance of the system L₁ is thencalculated according to the formula:

$\begin{matrix}{L_{1} = {\frac{X_{L}}{2\;\pi\; f_{1}}.}} & {{Equation}\mspace{14mu} 2}\end{matrix}$

This initial value of the inductance L₁ depends on the magneticpermeability μ₁ of the core of the tether 104, 310 according to Equation1, and is saved for reference. When detachment is desired, a highercurrent and/or a current with a different frequency than the signalingcurrent is applied through the resistive heater coil, causing the tether104, 310 to release the implant 112, 302 as previously described. Ifdetachment is successful, the tether 104, 310 will no longer be presentwithin the heater 106, 306 and the inside of the heater 106, 306 willfill with another material such as the patient's blood, contrast media,saline solution, or air. This material now within the heater core willhave a magnetic permeability μ₂ that is different than the tether coremagnetic permeability μ₁.

A second signaling current and frequency f₂ is sent through the heater106, 306 and is preferably the same as the first signaling current andfrequency, although one or both may be different without affecting theoperation of the system. Based on the second signaling current, a secondinductance L₂ is calculated. If the detachment was successful, thesecond inductance L₂ will be different (higher or lower) than the firstinductance L₁ due to the difference in the core magnetic permeabilitiesμ₁ and μ₂. If the detachment was unsuccessful, the inductance valuesshould remain relatively similar (with some tolerance for measurementerror). Once detachment has been confirmed by comparing the differencebetween the two inductances, an alarm or signal can be activated tocommunicate successful detachment to the user. For example, the alarmmight include a beep or an indicator light.

Preferably, the delivery system 100, 300 used according to thisinvention connects to a device that automatically measures inductance atdesired times, performs required calculations, and signals to the userwhen the implant device has detached from the delivery catheter.However, it should be understood that part or all of these steps can bemanually performed to achieve the same result.

The inductance between the attached and detached states can alsopreferably be determined without directly calculating the inductance.For example, the inductive resistance X_(L) can be measured and comparedbefore and after detachment. In another example, the detachment can bedetermined by measuring and comparing the time constant of the system,which is the time required for the current to reach a predeterminedpercentage of its nominal value. Since the time constant depends on theinductance, a change in the time constant would similarly indicate achange in inductance.

The present invention may also include a feedback algorithm that is usedin conjunction with the detachment detection described above. Forexample, the algorithm automatically increases the detachment voltage orcurrent automatically after the prior attempt fails to detach theimplant device. This cycle of measurement, attempted detachment,measurement, and increased detachment voltage/current continues untildetachment is detected or a predetermined current or voltage limit isattained. In this respect, a low power detachment could be firstattempted, followed automatically by increased power or time untildetachment has occurred. Thus, battery life for a mechanism providingthe detachment power is increased while the average coil detachment timeis greatly reduced.

Referring now to FIGS. 9 and 10, there is shown an embodiment of animplant delivery system 500 of the present invention. The implantdelivery system 500 and connector system 501 are generally similar tothe delivery pusher 301 and connector system 400, respectively,previously described in this application and shown in FIGS. 4 and 6.However, the implant delivery system 500 preferably includes a sensor502 for detecting when the implant device 302 has been advanced out of amicrocatheter 506 to a desired detachment location.

Generally, detachment of the implant device 302 is preferred once theimplant device 302 has fully exited the microcatheter 506. In thisrespect, the sensor 502 is positioned proximal to the implant device 302on the pusher 301. The sensor 502 detects a change in its environment(i.e., from a location within the microcatheter 506 to a locationoutside the microcatheter 506, within vasculature of a patient) which isconveyed along wires 504 to the connector system 501 and ultimately to ahuman interface or display device (not shown) near the user. Preferably,the human interface may include a meter, electronic display, audibletone, or the like.

In yet another preferred embodiment not shown in the figures, theimplant device 302 is utilized as a detection mechanism instead of or inaddition to the sensor 502. During navigation of the pusher 500 to thetarget deployment site within the vasculature, the pusher 500 remainswithin the microcatheter 506 and the coil of the implant device 302remains relatively straight, as it is confined by the walls defining theinternal lumen of the microcatheter 506. When the implant assembly isdeployed, the coil of the implant device 302 returns to a curvedconfiguration. The relative resistance of the coil of the implant device302 from its distal end to its proximal end changes as the coil changesfrom a straight to a coiled configuration. Thus, the change inresistance can be used as a location detection mechanism.

In one preferred embodiment, the sensor 502 may be a temperature sensor,detecting the temperature differential (e.g., a change from a normal orunbiased state) between the inside and outside of the microcatheter 506.Due to the relatively short period of time during which themicrocatheter 506 is disposed within the vasculature, the internaltemperature of the microcatheter 506 is typically cooler than thetemperature of the vasculature. Hence, the temperature increasesmarkedly as the sensor 502 reaches the detachment zone (i.e., a positionof preferred detachment) just outside the microcatheter 506. This jumpin temperature is thus used as an indication that the detachment zonehas been reached during the advancement of the implant device 302.

In another preferred embodiment, the sensor 502 is a pressure sensor fordetecting a pressure differential (e.g., a change from a normal orunbiased state) inside and outside of the microcatheter 506. Thepressure inside the microcatheter 506 is relatively constant, whereasthe pressure outside the microcatheter 506 varies with systole anddiastole of the blood stream. Hence, the sudden change of pressure froma relatively static reading to a dynamic reading can be used as anindication that the implant device 302 has been advanced to thedetachment zone.

In another preferred embodiment, the sensor 502 includes both anultrasound transceiver and sensor for detecting an ultrasounddifferential (e.g., a change from a normal or unbiased state) between aninside and outside of the microcatheter 506. The ultrasonic transceiversends ultrasonic waves and receives echoes of the waves in order todetermine distances to objects surrounding the transceiver. The walls ofthe microcatheter are much closer to the transceiver than the walls ofthe vasculature. Hence, the sudden increase in distance measured by thetransceiver can be used as an indication that the implant device 302 hasbeen advanced to the desired detachment zone.

Other sensors capable of detecting differential characteristics betweenan inside and outside of a microcatheter 506 may also be used.

In another preferred embodiment, the heater coil 306 may serve as asensor instead of or in addition to sensor 502. A resistancedifferential (e.g., a change from a normal or unbiased state) of theheater coil 306 may be measured as it is advanced through themicrocatheter 506. As the heater coil 502 exits the microcatheter 506,the environment surrounding the heater coil changes from dry andrelatively cool, to the warm blood filled environment of thevasculature. This change in environment affects the resistance of theheater coil 306 to a measurable degree. The following example isprovided to show data obtained using the heater coil 306 as a sensor:

Examples

A series of experiments were conducted to determine the resistancechange of heater coils as they are advanced through a microcatheter. Theprocedure used in order to obtain the data was as follows:

1. Obtain coil pusher

2. Prepare flow model.

3. Measure and record coil resistance on gold connector.

4. Advance coil pusher into microcatheter slightly beyond hub atproximal end.

5. Measure and record coil resistance. Mark data as 0% pusher length.

6. Advance coil pusher roughly 50% of entire length. Measure and recordcoil resistance. Mark data as 50% pusher length.

7. Repeat step 6 for 75% and 100% of pusher length, 100% being definedas the detachment zone exiting the distal end of the microcatheter.

8. Retract pusher and stop at above steps (75%, 50%, and 0%) and measureand record data.

9. Repeat cycle 3 times.

10. Measure and record coil pusher resistance one last time in air,outside of the microcatheter.

11. Detach implant and record results.

The following data were collected using various catheter types andheater coil materials. All resistance values shown in Tables 1-3 are inOhms. Blank values indicate no data was obtained. Percent pusher lengthis defined as percentage of the pusher inserted into microcatheter, e.g.100 percent equals detachment coil exited from distal end ofmicrocatheter. Resistance was measured from gold connectors at proximalend of pusher.

As a result of this data, a conclusion was drawn that of the two heatercoil materials tested, namely Stablohm and platinum, Stablohm had acoefficient of thermal resistivity that is much higher than that of theplatinum. Other materials with a higher coefficient of thermalresistivity may be used to provide a higher sensitivity of the readinginstrument. Moreover, the data show that there is a difference in theadvancing coil resistance of approximately 0.5 ohm for the platinum coiland 0.4 ohm for the stablohm (from 75%-100% mark).

Example 1

The microcatheter used for Example 1 was a Rapid Transit microcatheter.The heater coil material used was Stablohm 710. The flow temperature was99 degrees F. The heater coil resistance before testing was 42.1 Ohm.The heater coil resistance after the test was not recorded. Table 1shows the results of Example 1.

TABLE 1 Percent Advance Advance Retract Pusher Length Resistance 1Resistance 2 Resistance 1 0 42.1 42.1 42.1 50 42.2 — 42.2 75 42.5 42.5 —100 42.6 42.6 42.6

Example 2

The microcatheter used for Example 2 was an Excelsior 1018microcatheter. The heater coil material used was Platinum. The flowtemperature was 98.7 degrees F. The heater coil resistance beforetesting was 40.9 Ohm, and the heater coil resistance after the test was40.9 Ohm. Table 2 shows the results of Example 2.

TABLE 2 Percent Advance Advance Advance Retract Retract Retract PusherLength Resistance 1 Resistance 2 Resistance 3 Resistance 1 Resistance 2Resistance 3 0 40.8 41.0 41.0 41.0 41.0 41.0 50 40.9 41.2 41.1 41.1 41.141.1 75 41.2 — 41.3 — — 41.2 100 41.7 41.6 41.6 41.7 41.6 41.6

Example 3

The microcatheter used for Example 3 was an Excelsior SL10microcatheter. The heater coil material used was Platinum. The flowtemperature was 98.6 degrees F. The heater coil resistance beforetesting was 40.8 Ohm, and the heater coil resistance after the test was40.7 Ohm. Table 3 shows the results of Example 3.

TABLE 3 Percent Advance Advance Advance Retract Retract Retract PusherLength Resistance 1 Resistance 2 Resistance 3 Resistance 1 Resistance 2Resistance 3 0 40.8 40.9 40.8 40.9 40.8 40.7 50 41.0 41.0 41.0 41.0 40.941.0 75 41.1 41.2 41.2 41.2 41.1 41.2 100 41.6 41.6 41.7 41.6 41.6 41.7

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A system for determining when an implant hasadvanced out of a microcatheter comprising: a microcatheter having alumen and a distal end; a pusher disposed within the lumen of themicrocatheter; an implant device advanceable through the lumen by thepusher; and a sensor system comprising a resistance-type heater coillocated within the microcatheter and disposed proximate the implant; thesensor system calibrated to monitor a resistance of the heater coil,determine a resistance change due to blood entering the microcatheter,and signal when the implant has advanced completely out of the distalend of the microcatheter.
 2. The system of claim 1, further comprising ahuman interface device in data-flow communication with the sensor.
 3. Asystem for determining when an implant has advanced out of amicrocatheter comprising: a microcatheter having a lumen and a distalend; a pusher movable through the lumen of the microcatheter; an implantdevice advanceable through said lumen by the pusher; and a sensorassembly comprising a resistance-type heater coil disposed near thedistal end of the microcatheter; the sensor system configured to measureand monitor for a resistance change due to blood entering themicrocatheter, and signal when the implant has advanced entirely out ofsaid distal end of the microcatheter.
 4. The system of claim 3, whereinthe sensor assembly has been calibrated for use with the pusher.
 5. Asystem for determining when an implant has advanced out of a cathetercomprising: a catheter having a lumen and a distal end; a pusherdisposed within the lumen of the catheter; said implant advanceablethrough the lumen by the pusher; and a sensor system comprising aresistance-type heater coil disposed proximate the implant and withinthe catheter; the sensor system calibrated to monitor resistance of theheater coil, determine a resistance change due to blood entering thecatheter, and signal when the implant has advanced fully out of thedistal end of the catheter.
 6. The system of claim 5, wherein the sensorsystem has been calibrated for use with the pusher.